An explorative qualitative analysis of participants' experience of using kava versus placebo in an RCT

Many randomised controlled trials (RCT) have been conducted using Piper methysticum (kava), however no qualitative research exploring the experience of taking kava during a clinical trial has previously been reported. Patients and methods: A qualitative research component (in the form of semi structured and open ended written questions) was incorporated into an RCT to explore the experiences of those participating in a clinical trial of kava. The written questions were provided to participants at weeks 2 and 3 (after randomisation, after each controlled phase). The researcher and participants were blinded as to whether they were taking kava or placebo. Two open ended questions were posed to elucidate their experiences from taking either kava or placebo, Thematic analysis was undertaken and researcher triangulation employed to ensure analytical rigour. Key themes after the kava phases were a reduction In anxiety and stress, and calming or relaxing mental effects. Other themes related to improvement in sleep and In somatic anxiety symptoms. Results: Kava use did not cause any serious adverse reactions although a few respondents reported nausea or other gastrointestinal side effects. This represents the first documented qualitative Investigation of the experience of taking kava during a clinical trial. The primary themes involved anxiolytic and calming effects, with only a minor theme reflecting side effects. Our exploratory qualitative data was consistent with the significant quantitative results revealed In the study and provides additional support to suggest the trial results did not exclude any Important positive or negative effects (at least as experienced by the trial participants). © National Herbalists Association of Australia 2010